NCT06428305

Brief Summary

This study proves that the hygiene education given to pregnant women diagnosed with tract infection by explaining what they have learned increases the duration of genital health, thus ensuring the positive health development of women and protecting and improving their health. At the same time, it is aimed to inform the professional "tell what you have learned" method and to guide the practices of those working in the field of health. The research will be conducted in a randomized control design with a pretest-posttest control group. The population of the research will consist of pregnant women who were followed up in the relevant hospital and who met the inclusion criteria on the dates the research was conducted. The number of samples for the study was determined as 36 participants, 18 in each group. While hygiene training will be given to the intervention group using the tell-what-you-learned method, no training will be given to the control group. Personal Information Form and Genital Hygiene Behavior Scale will be used as data collection tools in the research. Data will be collected at the first encounter, day 7, day 21, and day 30. In evaluating the data, the suitability of the variables to normal distribution will be examined using visual analytical methods. When comparing application results within and between groups, parametric or nonparametric tests will be used depending on whether they show a normal distribution or not, and t test or Mann-Withney U Test will be used to compare the difference between two groups. Wilcoxon test will be used to analyze pre- and post-intervention results within the same group. Statistical significance level will be accepted as p\<0.05. When the literature is examined, there are studies on different health education plans for women diagnosed with urinary tract infection during pregnancy, but since there is no research on the tell-what-you-learned method, it is an original study, and at the same time, the previous knowledge levels of pregnant women diagnosed with UTI were learned and the effect of the education given on their behavior was examined. It is thought that this teaching method will contribute positively to the knowledge level and behavior of women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

29 days

First QC Date

May 20, 2024

Last Update Submit

September 12, 2025

Conditions

Keywords

PregnantGenital hygieneTeach Back MethodHealth EducatioUrinary system ınfections

Outcome Measures

Primary Outcomes (1)

  • The Scale of Genital Hygiene Behaviors

    It was developed by Karahan (2017) to evaluate genital hygiene behaviors in women. General hygiene habits (top 12 items), menstrual hygiene (13th item on the five-point likert scale).-20. substances) and abnormal finding awareness (21-23. it consists of three sub-dimensions (substances) and a total of 23 substances. The cronbach alpha value of the entire scale is 0.80, and it is stated that the general hygiene sub-dimension is 0.70, the menstrual hygiene sub-dimension is 0.74, and the abnormal finding awareness sub-dimension is 0.81. 7 of the scale., 14., 19., 20., 23. items are scored in reverse. The lowest 23 highest 115 points are taken from the scale and the high scores indicate that genital hygiene behavior is positive (Karahan, 2017).

    1. day, 7. day, 21, day, 30.. day

Study Arms (2)

The intervention group receiving planned education on genital hygiene using the teach-back method

EXPERIMENTAL

All pregnant women diagnosed with UTI at the maternity outpatient clinic are prescribed antibiotics containing the active substance fosfomycin tromethamol, which is recommended for uncomplicated urinary tract infections of adults. The duration of the antibiotic's effect is seven days (Due date). After completing the treatment process determined according to the physician's request, training and counseling will be provided using the Genital Hygiene Training Guide based on the Tell me what you have learned method. In this context, 4 interviews will be held during the project.

Other: Providing hygiene education based on the method of teaching what has been learned in the context of a genital hygiene guide

Control Group

NO INTERVENTION

Control Group: Research data were collected from pregnant women who were in the control group at the December intervals with the experimental group, as shown in the Flow Chart of the study. After the completion of the study, this group will also be given an education and training booklet.

Interventions

As shown in the Flow Chart of the study, research data were collected from pregnant women who were in the control group at the December intervals with the experimental group. After the completion of the study, this group will also be given an education and training booklet.

The intervention group receiving planned education on genital hygiene using the teach-back method

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women who have been diagnosed with a urinary tract infection
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Able to read and write Turkish,
  • Those between the ages of 18-35 December,
  • Diagnosed with urinary tract infection,
  • Pregnant women who are open to communication (who are competent to understand and answer questions) will be included in the sample.

You may not qualify if:

  • Leaving the research of his own accord,
  • Having a diagnosis related to risky pregnancy other than the diagnosis of urinary tract infection
  • With a history of psychiatric illness (self-report),
  • Pregnant women with a history of gynecological diseases (self-information) will be excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42020, Turkey (Türkiye)

Location

Study Officials

  • Hediye KARAKOÇ, assistant professor

    KTO Karatay University

    STUDY DIRECTOR
  • Arzu ÇİFTÇİ, post graduate

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The statistician will be blinded in the research. Researcher blinding cannot be done because he is a practitioner. But the researcher will open the envelope created by the statistician just before the application and find out which group the mother belongs to. In order to prevent bias in the evaluation of the data, groups will be coded as A and B, and the analysis of the data will be carried out by an independent statistical expert. After the analysis and interpretation of the data are completed, the codes of the intervention and control groups of the study will be revealed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The intervention group receiving planned education on genital hygiene using the teach-back method and the control group not receiving education
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate student

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

April 22, 2024

Primary Completion

May 21, 2024

Study Completion

February 28, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

have no plans to make individual participant data (IPD) available to other researchers.

Locations